A clinical protocol for analysis of the structural integrity of the Medtronic CoreValve System® frame and its application in patients with 1-year minimum follow-up

Nicolo Piazza; Eberhard Grube; Ulrich Gerckens; Gerhard Schuler; Axel Linke; Peter Den Heijer; Jan Kovacs; Tom Spyt; Jean Claude Laborde; Marie Angele Morel; Rutger Jan Nuis; Hector M. Garcia-Garcia; Peter De Jaegere; Patrick W. Serruys

doi:10.4244/EIJV5I6A112

A clinical protocol for analysis of the structural integrity of the Medtronic CoreValve System® frame and its application in patients with 1-year minimum follow-up

Nicolo Piazza, Eberhard Grube, Ulrich Gerckens, Gerhard Schuler, Axel Linke, Peter Den Heijer, Jan Kovacs, Tom Spyt, Jean Claude Laborde, Marie Angele Morel, Rutger Jan Nuis, Hector M. Garcia-Garcia, Peter De Jaegere, Patrick W. Serruys

Research output: Contribution to a Journal (Peer & Non Peer) › Article › peer-review

13 Citations (Scopus)

Abstract

Aims: The optimal clinical protocol to detect fractures of transcatheter aortic valves is unknown. To the best of our knowledge, there are no published reports describing stent or frame fractures following transcatheter aortic valve implantation. The purpose of this study is two-fold: (1) to determine the optimal fluoroscopic protocol to identify potential fractures of the Medtronic CoreValve® frame; and (2) to implement this protocol in the analysis of the fluoroscopic films of patients implanted with the CoreValve® device with 1-year minimum follow-up. Methods and results: Considering the resolution of fluoroscopy (∼ 0.2 mm), we used a 0.2 mm diamondcutter to create a single fracture in a single strut of two CoreValve® frames. An intact CoreValve® prosthesis was used as control. These prostheses were subsequently implanted in post-mortem heart specimens. A protocol involving still frames and rotational (left-right and cranial-caudal) fluoroscopic imaging was then applied to the heart specimens. The experimentally induced fractures were detectable on the rotational cine runs (left-right and cranial-caudal); in some of the fixed acquisition sequences, however, the fractures were undetectable. The fluoroscopic protocol was retrospectively applied to the films of 58 patients who underwent implantation with the CoreValve System® between October 2005 and August 2008 and had at least 1-year follow-up. The mean and median follow-up times were 22 months and 24 months, respectively (range 12 to 36 months). Rotational cine films (only left-right lateral) were available in 39 patients (60%). No frame fractures of the CoreValve® frame were identified. Conclusions: Rotational cine runs in the left-right and cranial-caudal directions should be mandatory in the clinical assessment of the structural integrity of the CoreValve® frame. No frame fractures were identified in 58 patients implanted with the Medtronic CoreValve® device with 2-year mean follow-up.

Original language	English
Pages (from-to)	680-686
Number of pages	7
Journal	EuroIntervention
Volume	5
Issue number	6
DOIs	https://doi.org/10.4244/EIJV5I6A112
Publication status	Published - Jan 2010
Externally published	Yes

Keywords

Aortic stenosis
Aortic valve disease
Transcatheter aortic valve implantation
Valve fracture
Valvular heart disease

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.4244/EIJV5I6A112

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Piazza, N., Grube, E., Gerckens, U., Schuler, G., Linke, A., Den Heijer, P., Kovacs, J., Spyt, T., Laborde, J. C., Morel, M. A., Nuis, R. J., Garcia-Garcia, H. M., De Jaegere, P., & Serruys, P. W. (2010). A clinical protocol for analysis of the structural integrity of the Medtronic CoreValve System® frame and its application in patients with 1-year minimum follow-up. EuroIntervention, 5(6), 680-686. https://doi.org/10.4244/EIJV5I6A112

@article{2c61fde9dc3b4eb4b1c7163b7ae42eeb,

title = "A clinical protocol for analysis of the structural integrity of the Medtronic CoreValve System{\textregistered} frame and its application in patients with 1-year minimum follow-up",

abstract = "Aims: The optimal clinical protocol to detect fractures of transcatheter aortic valves is unknown. To the best of our knowledge, there are no published reports describing stent or frame fractures following transcatheter aortic valve implantation. The purpose of this study is two-fold: (1) to determine the optimal fluoroscopic protocol to identify potential fractures of the Medtronic CoreValve{\textregistered} frame; and (2) to implement this protocol in the analysis of the fluoroscopic films of patients implanted with the CoreValve{\textregistered} device with 1-year minimum follow-up. Methods and results: Considering the resolution of fluoroscopy (∼ 0.2 mm), we used a 0.2 mm diamondcutter to create a single fracture in a single strut of two CoreValve{\textregistered} frames. An intact CoreValve{\textregistered} prosthesis was used as control. These prostheses were subsequently implanted in post-mortem heart specimens. A protocol involving still frames and rotational (left-right and cranial-caudal) fluoroscopic imaging was then applied to the heart specimens. The experimentally induced fractures were detectable on the rotational cine runs (left-right and cranial-caudal); in some of the fixed acquisition sequences, however, the fractures were undetectable. The fluoroscopic protocol was retrospectively applied to the films of 58 patients who underwent implantation with the CoreValve System{\textregistered} between October 2005 and August 2008 and had at least 1-year follow-up. The mean and median follow-up times were 22 months and 24 months, respectively (range 12 to 36 months). Rotational cine films (only left-right lateral) were available in 39 patients (60\%). No frame fractures of the CoreValve{\textregistered} frame were identified. Conclusions: Rotational cine runs in the left-right and cranial-caudal directions should be mandatory in the clinical assessment of the structural integrity of the CoreValve{\textregistered} frame. No frame fractures were identified in 58 patients implanted with the Medtronic CoreValve{\textregistered} device with 2-year mean follow-up.",

keywords = "Aortic stenosis, Aortic valve disease, Transcatheter aortic valve implantation, Valve fracture, Valvular heart disease",

author = "Nicolo Piazza and Eberhard Grube and Ulrich Gerckens and Gerhard Schuler and Axel Linke and \{Den Heijer\}, Peter and Jan Kovacs and Tom Spyt and Laborde, \{Jean Claude\} and Morel, \{Marie Angele\} and Nuis, \{Rutger Jan\} and Garcia-Garcia, \{Hector M.\} and \{De Jaegere\}, Peter and Serruys, \{Patrick W.\}",

year = "2010",

month = jan,

doi = "10.4244/EIJV5I6A112",

language = "English",

volume = "5",

pages = "680--686",

journal = "EuroIntervention",

issn = "1774-024X",

publisher = "Europa Group",

number = "6",

}

Piazza, N, Grube, E, Gerckens, U, Schuler, G, Linke, A, Den Heijer, P, Kovacs, J, Spyt, T, Laborde, JC, Morel, MA, Nuis, RJ, Garcia-Garcia, HM, De Jaegere, P & Serruys, PW 2010, 'A clinical protocol for analysis of the structural integrity of the Medtronic CoreValve System® frame and its application in patients with 1-year minimum follow-up', EuroIntervention, vol. 5, no. 6, pp. 680-686. https://doi.org/10.4244/EIJV5I6A112

A clinical protocol for analysis of the structural integrity of the Medtronic CoreValve System® frame and its application in patients with 1-year minimum follow-up. / Piazza, Nicolo; Grube, Eberhard; Gerckens, Ulrich et al.
In: EuroIntervention, Vol. 5, No. 6, 01.2010, p. 680-686.

Research output: Contribution to a Journal (Peer & Non Peer) › Article › peer-review

TY - JOUR

T1 - A clinical protocol for analysis of the structural integrity of the Medtronic CoreValve System® frame and its application in patients with 1-year minimum follow-up

AU - Piazza, Nicolo

AU - Grube, Eberhard

AU - Gerckens, Ulrich

AU - Schuler, Gerhard

AU - Linke, Axel

AU - Den Heijer, Peter

AU - Kovacs, Jan

AU - Spyt, Tom

AU - Laborde, Jean Claude

AU - Morel, Marie Angele

AU - Nuis, Rutger Jan

AU - Garcia-Garcia, Hector M.

AU - De Jaegere, Peter

AU - Serruys, Patrick W.

PY - 2010/1

Y1 - 2010/1

N2 - Aims: The optimal clinical protocol to detect fractures of transcatheter aortic valves is unknown. To the best of our knowledge, there are no published reports describing stent or frame fractures following transcatheter aortic valve implantation. The purpose of this study is two-fold: (1) to determine the optimal fluoroscopic protocol to identify potential fractures of the Medtronic CoreValve® frame; and (2) to implement this protocol in the analysis of the fluoroscopic films of patients implanted with the CoreValve® device with 1-year minimum follow-up. Methods and results: Considering the resolution of fluoroscopy (∼ 0.2 mm), we used a 0.2 mm diamondcutter to create a single fracture in a single strut of two CoreValve® frames. An intact CoreValve® prosthesis was used as control. These prostheses were subsequently implanted in post-mortem heart specimens. A protocol involving still frames and rotational (left-right and cranial-caudal) fluoroscopic imaging was then applied to the heart specimens. The experimentally induced fractures were detectable on the rotational cine runs (left-right and cranial-caudal); in some of the fixed acquisition sequences, however, the fractures were undetectable. The fluoroscopic protocol was retrospectively applied to the films of 58 patients who underwent implantation with the CoreValve System® between October 2005 and August 2008 and had at least 1-year follow-up. The mean and median follow-up times were 22 months and 24 months, respectively (range 12 to 36 months). Rotational cine films (only left-right lateral) were available in 39 patients (60%). No frame fractures of the CoreValve® frame were identified. Conclusions: Rotational cine runs in the left-right and cranial-caudal directions should be mandatory in the clinical assessment of the structural integrity of the CoreValve® frame. No frame fractures were identified in 58 patients implanted with the Medtronic CoreValve® device with 2-year mean follow-up.

AB - Aims: The optimal clinical protocol to detect fractures of transcatheter aortic valves is unknown. To the best of our knowledge, there are no published reports describing stent or frame fractures following transcatheter aortic valve implantation. The purpose of this study is two-fold: (1) to determine the optimal fluoroscopic protocol to identify potential fractures of the Medtronic CoreValve® frame; and (2) to implement this protocol in the analysis of the fluoroscopic films of patients implanted with the CoreValve® device with 1-year minimum follow-up. Methods and results: Considering the resolution of fluoroscopy (∼ 0.2 mm), we used a 0.2 mm diamondcutter to create a single fracture in a single strut of two CoreValve® frames. An intact CoreValve® prosthesis was used as control. These prostheses were subsequently implanted in post-mortem heart specimens. A protocol involving still frames and rotational (left-right and cranial-caudal) fluoroscopic imaging was then applied to the heart specimens. The experimentally induced fractures were detectable on the rotational cine runs (left-right and cranial-caudal); in some of the fixed acquisition sequences, however, the fractures were undetectable. The fluoroscopic protocol was retrospectively applied to the films of 58 patients who underwent implantation with the CoreValve System® between October 2005 and August 2008 and had at least 1-year follow-up. The mean and median follow-up times were 22 months and 24 months, respectively (range 12 to 36 months). Rotational cine films (only left-right lateral) were available in 39 patients (60%). No frame fractures of the CoreValve® frame were identified. Conclusions: Rotational cine runs in the left-right and cranial-caudal directions should be mandatory in the clinical assessment of the structural integrity of the CoreValve® frame. No frame fractures were identified in 58 patients implanted with the Medtronic CoreValve® device with 2-year mean follow-up.

KW - Aortic stenosis

KW - Aortic valve disease

KW - Transcatheter aortic valve implantation

KW - Valve fracture

KW - Valvular heart disease

UR - https://www.scopus.com/pages/publications/77956644217

U2 - 10.4244/EIJV5I6A112

DO - 10.4244/EIJV5I6A112

M3 - Article

C2 - 20142218

AN - SCOPUS:77956644217

SN - 1774-024X

VL - 5

SP - 680

EP - 686

JO - EuroIntervention

JF - EuroIntervention

IS - 6

ER -

A clinical protocol for analysis of the structural integrity of the Medtronic CoreValve System® frame and its application in patients with 1-year minimum follow-up

Abstract

Keywords

UN SDGs

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